Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System

Phase 2

Terminated

• Conditions: Thyroid Carcinoma; Radioactive Iodine Level
• Interventions: Drug: Artificial Tears

• Registration Number: NCT04327999
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

The purpose of this study is to explore whether administration of preservative free artificial tears will decrease the level of detectable radioiodine in the tears and nasolacrimal duct system of patients undergoing radioiodine therapy for thyroid carcinoma and thus decrease the risk of developing radioactive iodine associated nasolacrimal duct obstruction.

Detailed Description

Primary Objective:

- To assess whether use of preservative free artificial tears following radioactive iodine administration will lower the level of radioactive iodine in the tears of patients treated with radioactive iodine for thyroid carcinoma.

Secondary Objective:

- To evaluate whether artificial tears would be an effective preventative intervention to decrease the risk of developing nasolacrimal duct stenosis, which has been associated with radioactive iodine administration.

Study Timeline

• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-28
• Study First Posted: 2020-03-31
• Study Start: 2020-10-05
• Primary Completion: 2023-09-25
• Study Completion: 2023-09-25
• Results First Submitted: 2023-11-18
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Results First Posted: 2024-01-18
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Radio-iodine therapy for thyroid cancer
• Radioiodine therapy ≥100mCi
• Patient wears soft contacts on both eyes

Exclusion Criteria

• Use of eye drops, other than artificial tears

• History of periocular trauma with tear duct involvement/lacrimal gland trauma

• History of lacrimal drainage disease: canaliculitis, dacryocystitis

• Prior radiotherapy

• Current or prior use of chemotherapy drugs (i.e. 5-fluorouracil, docetaxel)

• Medical conditions that predispose to NLD stenosis

  • Sarcoid
  • Granulomatosis with polyangiitis
  • Chronic lymphocytic leukemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Preservative free artificial tears	Artificial Tears	Day 1, patients will self-administer artificial tears every 15 minutes for 2 hours followed by every 30 minutes for at least 4 hours or until bedtime at night. On Day 2, patients will self-administer artificial tears every 1 hour for 12 hours. On Day 3, patients will self-administer artificial tears four times that day. On Day 4, patients will self-administer tears twice that day. Patients will be instructed to wear their contact lenses throughout their waking hours.

Primary Outcome Measures

Name	Time	Method
Change in Level of Radioactive Iodine in Tears	Over a 4 day period	The radioactive iodine activity level in the tears will be measured, as collected via contact lenses. Each patient will have a control eye and an experimental eye that received artificial tears. The control eye has no intervention. The radioactive iodine activity level will be measured over four days, with Day 1 occurring on the Day of systemic radioactive iodine therapy. On each of the four days, the level of radioactive iodine will be compared between the control and experimental eyes to see if there is a statistical difference between the control and experimental eyes.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States